TOPIC: medhelp.org

Corrigible-capable of being corrected or reformed, like moi for example.......

I was kidding.

But seriously, maybe that's the answer. The FDA can't keep people from participating in a trial, right? To be in the trial you need the meds.

The part where the FDA said the meds are unapproved, in the 1980's they allowed the HIV group to bring meds from Mexico. I'm asking some of the people who opened Buyers Clubs what they were allowed to import. It would be discrimination to allow one group to import but not the others.

P.

This business of what is approved or not seem to me to be a real can of worms.
Here we have brand name drugs that are approved and under patent, while their generic versions are deemed to be not approved.

But hang on. Pharmacies all over are stocked with generic versions of brand name drugs, many manufactured in India, and nobody is questioning it. Why is that? Is it because the patents on all of them ran out so it's ok to import them now?

Gosh I'm confused. The NHS is practically kept afloat by the use of Indian generics, yet I have never seen any trials run on them or suggestions that they were sub-standard. Were they all considered to be suspect until the patents ran out, at which time they magically became AOK, bona fida, approved?

Is 'approved' in this case just another name for 'patent-protected?
Cos that is an interesting choice of a word which is usually understood to mean a drug which has been tested for safety and efficacy and passed by the FDA.

dt

One solution to Gilead's blatant profiteering would be for the FDA to recognize approved generic drugs like sofosbuvir and ledipasvir and allow import from legitimate sources. Force Gilead to fight a patent infringement battle instead if requiring sick people to fight to get them. Then all the nasty details would emerge in the press as the case progressed. How the poor company was simply trying to recoup research costs to be able to continue its noble cause.
M

I just wanted to post an observation....

Mike you said the only packages you know of being detained were both originated in India.

Gilead has stated they are going to be vigilant about making sure Indian generics don't make there way to countries that India has not been approved to send meds to. The packaging on the Indian generic Ledifos has a line that reads "For sale in India only". So maybe Australia or Bangladesh will not be on the radar to the extent that India is, given that India is the country that everyone is aware that generics will be produced there due to all the media coverage. So Gilead is probably focusing it's influence over FDA to scrutinize Indian drug exports to USA. That is probably where the majority of Harvoni or Sovaldi exports will be coming from. So from a USA perspective, an individual is probably better off trying to import from Australia or Bangladesh.

Good observation. I agree.

Yes, that thought has been circling in my brain ever since the first issue with Indian meds. Then the second one happened. I don't believe in coincidence.
M

Greedfighter wrote:
As an Australian, I don't have a horse in this particular race but thinking about the situation:

- Could it just be coincidence? Or because currently the majority of unaccompanied imports are being made from India?
- If the Indian shipments are being targeted, is the suggested approach just rewarding Gilead's behaviour?
- Possibly eventually narrowing the window that the FDA has to focus on?

Obviously my above thoughts aren't very helpful to individual importers but possibly something to consider for overall U.S. strategy?

I think there needs to be more data before anyone needs to start worrying about importing from one country over another. How many are coming in without any issues at all? How many people import without posting information here? Lots of questions. Not many answers.
M